COVID-19 Infection and Reproductive Health in Infertile Women

Infertility, Female Clinical Trial

— COVINF  

Official title:

Post-COVID-19 Infection and Reproductive Health in Women Undergoing I.V.F. Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05435430
• Other study ID #: AOOR VILLA SOFIA CERVELLO
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: June 2022
• Source: University of Palermo
• Contact: Giuseppe Gullo, MD.Ph.D
• Phone: +393336103998
• Email: gullogiuseppe[@]libero.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An increased number of women has been infected by COVID-19 in the last 2 years SARS-CoV-2 infection could have a role in potential disturbances on hormon levels and human fertility Has not completely demonstrated COVID-19 effects on female reproductive function and further research can be undertaken. The proposed multicenter study will be simple and rapid, and attractive for the scientific community.

Description:

COVID-19 virus is classified as a respiratory disease that drastically changed our daily life and perspective (1) can be mainly transmitted via respiratory droplets, however, there are recently published reports suggested its ability to transmit via sexual intercourse, assisted reproductive technology (ART) treatments, pregnancy, and nursing. ART specialists should be precautious, carefully following the situation while contributing by sharing novel evidence to counsel our patients (2). However, there are no comprehensive reviews to explore the association between COVID-19 and female fertility comprehensively.Its of major importance to provide in-depth research explaining the underlying mechanism of SARS-CoV-2 infection and its impact on human reproductive organs and fertility (3). Ovarian reserve is a key determinant of female fertility. In this study we observe the potential effects of SARS-CoV-2 infection on the principal indicators of ovarian reserve function as anti-Müllerian hormone (AMH); basal follicle-stimulating hormone (FSH), basal luteinising hormone (LH) basal oestradiol (E2) antral follicle count (AFC). Questions regarding the potential risks of sexual transmission during intercourse and/or application of ART, vertical transmission (throughout pregnancy, delivery, and breastfeeding), the health of pregnant and postpartum women, and fetal or postnatal health problems of neonates/children remain largely unanswered (4,5).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 1, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

Women 24-43 years of age Previous history of COVID-19 infection INFERTILITY DIAGNOSIS Exclusion Criteria: Women with current symptoms of COVID-19 infection Positive for HIV or the presence of active viral hepatitis Previosuly ovarian cancer, removal of ovaries or gonadotoxic treatments

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Other:
• PERSPECTIVE, MULTICENTRIC and observational
we will enroll women with 25-45ys old and previously SARS-COV2 infection. first outcome to be investigate the impact of SARS-COV2 infection on female reproductive health and the main clinical-laboratory parameters (FSH, LH, AMH) relating to women with procreative research, in a path of medically procreation assisted programm and on any quantitative variations, duration and periodicity of the menstrual cycle after Covid infection compared to the pre-infection period.

Locations

Country	Name	City	State
Italy	Aoor Villa Sofia Cervello	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
University of Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (7)

3. World Health Organization. Coronavirus disease 2019 (COVID-2019) situation Report-49, 2020. Available: https://www.who.int/ emergencies/diseases/novel-coronavirus-2019 [Accessed 2 Sep 2020].

D'Ippolito S, Turchiano F, Vitagliano A, Scutiero G, Lanzone A, Scambia G, Greco P. Is There a Role for SARS-CoV-2/COVID-19 on the Female Reproductive System? Front Physiol. 2022 Mar 2;13:845156. doi: 10.3389/fphys.2022.845156. eCollection 2022. Review. — View Citation

Li F, Lu H, Zhang Q, Li X, Wang T, Liu Q, Yang Q, Qiang L. Impact of COVID-19 on female fertility: a systematic review and meta-analysis protocol. BMJ Open. 2021 Feb 25;11(2):e045524. doi: 10.1136/bmjopen-2020-045524. — View Citation

Li R, Yin T, Fang F, Li Q, Chen J, Wang Y, Hao Y, Wu G, Duan P, Wang Y, Cheng D, Zhou Q, Zafar MI, Xiong C, Li H, Yang J, Qiao J. Potential risks of SARS-CoV-2 infection on reproductive health. Reprod Biomed Online. 2020 Jul;41(1):89-95. doi: 10.1016/j.rbmo.2020.04.018. Epub 2020 Apr 30. Review. — View Citation

Markiewicz-Gospodarek A, Wdowiak P, Czeczelewski M, Forma A, Flieger J, Januszewski J, Radzikowska-Büchner E, Baj J. The Impact of SARS-CoV-2 Infection on Fertility and Female and Male Reproductive Systems. J Clin Med. 2021 Sep 29;10(19). pii: 4520. doi: 10.3390/jcm10194520. Review. — View Citation

Maroufizadeh S, Karimi E, Vesali S, Omani Samani R. Anxiety and depression after failure of assisted reproductive treatment among patients experiencing infertility. Int J Gynaecol Obstet. 2015 Sep;130(3):253-6. doi: 10.1016/j.ijgo.2015.03.044. Epub 2015 J — View Citation

Reis S, Xavier MR, Coelho R, Montenegro N. Psychological impact of single and multiple courses of assisted reproductive treatments in couples: a comparative study. Eur J Obstet Gynecol Reprod Biol. 2013 Nov;171(1):61-6. doi: 10.1016/j.ejogrb.2013.07.034. Epub 2013 Aug 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main outcome	To investigate how the SARS-COV2 infection affects the female reproductive health and the main clinical-laboratory parameters (FSH, LH, AMH) relating to women with procreative research in a path of medically assisted procreation and any quantitative variations, duration and periodicity of the menstrual cycle after Covid infection.19 compared to the pre-infection period.	18 months
Secondary	secondary outcomes	Quantification of the number of good quality oocytes (MII) . Number of embryos on day 3 (Morula) or day 5 (blastocyst) of development transferred to the patients.; Thickness of the endometrium at the time of embryo transfer (ET).	18 months